Professional Documents
Culture Documents
www.biomat.net 10/1/2004
1. Marrow stem cells could heal broken 2.
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bones, Betterhumans Newly grown kidneys can sustain life in rats, Bio.com Doctors grow new jaw in man's back, CNN FDA approves implanted lens for nearsightedness, CNN Stent recall may raise quality expectations, Medical Device Link
A biomaterial is "any substance (other than drugs) or combination of substances synthetic or natural in origin, which can be used for any period of time, as a whole or as a part of a system which treats, augments, or replaces any tissue, organ, or function of the body". Biocompatibility The ability of a material to perform with an appropriate host response in a specific application
Host Response The response of the host organism (local and systemic) to the implanted material or device.
In- Vivo Services: Rabbit Pyrogen USP Class Testing Sensitization Implantation Sub-Chronic/Chronic Toxicity Intracutaneous Reactivity Irritation Testing Necropsy Services Histology Services
In-Vitro Services: Cytotoxicity Hemolysis Complement Activation PT/PTT Testing AMES Mutagenicity Carcinogencity Testing
Our In-vitro toxicity services are performed by our experienced and fully trained microbiologists
Keywords
Metallic/glass/Polymeric/Ceramic/Composite
Fracture/fatigue/creep/corrosion/degradation Tissue response/healing/biocompatibility/host
Biocompatibility
Test Conditions:
pH pO2 Temperature Mechanical Stress Stress Cycles (per year) Value 6.8 7.0 7.15-7.35 2-40 40 100 37 28 7 -2 4x108 N m-2 4x105 N m 3x106 7 5x10 - 4x10 Location Intracellular Interstitial Blood Interstitial (mm Hg) Venous Arterial Normal Core Normal Skin Muscle (peak stress) Tendon (peak stress) Peristalsis Heart muscle contraction
Bulk Material
Test Animals
Rabbits ear, skin, pyrogen Guinea Pigs skin, esp C@ Mice genotoxicity Horseshoe Crab endotoxins Pig implant Bacteria - genotoxicity Test actual & elutants & extracts People long term
An Interdisciplinary Field
Bioengineers Material Scientists Immunologists Chemists Biologists Surgeons ...
Journals
Biomaterials World News Materials Today Nature Journal of Biomedical Materials Research Cells and Materials Journal of Biomaterials Science Artificial Organs ASAIO Transactions Tissue Engineering Annals of Biomedical Engineering Medical Device Link see: http://www.biomat.net/biomatnet.asp?group=1_5
dentistry over 2000 years ago, Cu not good. Ivory & wood teeth Aseptic surgery 1860 (Lister) Bone plates 1900, joints 1930 Turn of the century, synthetic plastics came into use
WWII, shards of PMMA unintentionally got lodged into eyes of aviators Parachute cloth used for vascular prosthesis
Uses of Biomaterials
Replace diseased part dialysis Assist in healing sutures Improve function contacts Correct function spinal rods Correct cosmetic nose, ear Aid dx probe Aid tx catheter Replace rotten amalgam Replace dead - skin
Acute toxicity (cytotoxicity) arsenic Sub chronic/chronic Pb Sensitization Ni, Cu Genotoxicity Carcinogenicity Reproductive &/or developmental Pb Neurotoxicity Immunotoxicity Pyrogen, endotoxins
contact (24 Hr, 1-30 Days, >30 days) See table for details ISO 10993 required for European Union Certification see flowchart for exemptions See Device Categories & examples Harmonization in process
Intraocular Lens
3 basic materials - PMMA, acrylic, silicone
Vascular Grafts
http://www.totaljoints.info/Hip.jpg
SEM displaying the cross section of a composite disk, which had been seeded with cultured bone marrow stromal cells.
... in the shape of a nose (left) is "seeded" with cells called chondrocytes that replace the polymer with cartilage over time (right) to make a suitable implant.
Evolution of Biomaterials
Structural
reconstruction Biosensors, Biomimetic , and smart devices Controlled Drug Delivery/ Targeted delivery Biohybrid organs and Cell immunoisolation
New biomaterials - bioactive, biodegradable, inorganic New processing techniques
Polymers
Orthopedic screws/fixation
Metals
Synthetic BIOMATERIALS
Ceramics
Dental Implants
Dental Implants
Implantable Microelectrodes
Semiconductor Materials
Biosensors
vascular graft
Biodegradable nerve
guidance channel
and therapeutic modalities Interface of biotechnology and traditional engineering Significant industrial growth in the next 15 years -- potential of a multi-billion dollar industry
Biomaterials Companies
BioForma Research & Consulting, Inc., fibrinolytic systems, protein-material interactions Baxter International develops technologies related to the blood and circulatory system. Biocompatibles Ltd. develops commercial applications for technology in the field of biocompatibility.
Carmeda makes a biologically active surface that interacts with and supports the bodys own control mechanisms
Collagen Aesthetics Inc. bovine and human placental sourced collagens, recombinant collagens, and PEG-polymers Endura-Tec Systems Corp. bio-mechanical endurance testing ofstents, grafts, and cardiovascular materials Howmedica develops and manufactures products in orthopaedics. MATECH Biomedical Technologies, development of biomaterials by chemical polymerization methods. Medtronic, Inc. is a medical technology company specializing in implantable and invasive therapies. Molecular Geodesics Inc., biomimetic materials for biomedical, industrial, and military applications Polymer Technology Group is involved in the synthesis, characterization, and manufacture of new polymer products. SurModics, offers PhotoLink(R) surface modification technology that can be used to immobilize biomolecules W.L. Gore Medical Products Division, PTFE microstructures configured to exclude or accept tissue ingrowth. Zimmer, design, manufacture and distribution of orthopaedic implants and related equipment and supplies
architecture and arrangement in vitro To better understand extracellular and intracellular modulators of cell function To develop novel materials and processing techniques that are compatible with biological interfaces To find better strategies for immune acceptance